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INTERFERON SCIENCES ORAL ALPHA INTERFERON STUDY AT MOUNT SINAI

Executive Summary

INTERFERON SCIENCES ORAL ALPHA INTERFERON STUDY AT MOUNT SINAI Medical Center is currently enrolling subjects with AIDS-Related Complex. To date about 12 to 16 individuals with ARC have been enrolled in the study, which plans to enroll a total of 45 patients. Patients who have had Kaposi's sarcoma, Pneumocystis carinii pneumonia or any other major opportunistic infection are not eligible for the study. Mount Sinai is also planning a second study with the alpha interferon, called Kemron, in the fall. It will be a dose ranging study in AIDS and ARC patients. The Mount Sinai study follows preliminary results with the drug in Africa. One multicenter study organized by the World Health Organization with oral alpha interferon produced a July report of "inconclusive results" and did not replicate earlier positive findings with the drug. "Mild clinical improvement" was observed in 50%-60% of 108 people with AIDS treated with Kemron, but "it was impossible to affirm that it was due to the effect of the drug," WHO said. The clinical effect of the drug could not be determined, according to WHO, because the study was uncontrolled for placebo effect and many patients were receiving other care for HIV-related conditions. WHO also noted that a controlled study conducted in Zimbabwe "did not show any clinical difference between the treated and the untreated group of patients." The four-week study, conducted in institutions in several African nations, including Cote d'Ivoire, Congo, Zimbabwe, Kenya, and Cameroon, evaluated the drug for clinical improvement, reversion to HIV-seronegativity and increases in CD4 cell counts. WHO reported that "none of the 60 patients who were retested at the end of the multicenter study for presence of HIV antibody became HIV-seronegative after treatment." There was a transient increase in the number of CD4 cells in the patients peripheral blood, "but the number of these cells were observed to drop again after the first two weeks of treatment," WHO said. WHO noted, however, that the Kenya Medical Research Institute (KEMRI) recently reported that approximately 10% of patients in one study became HIV-seronegative following Kemron treatment. In another study conducted by KEMRI director Davy Koech, PhD, 38 symptomatic and two asymptomatic HIV seropositive patients were treated with 2 IU/kg oral alpha interferon once daily for six weeks. After two weeks of therapy, all but four of the patients had an average increase in CD4 count of 291 cells/mm. The average increase after four weeks was 459 cells/mm. Eight patients in the KEMRI study seroconverted at two to four weeks into therapy, as confirmed by both ELISA and Western Blot tests. The patients "have continued to be seronegative at subsequent testing through mid-February 1990," Koech, et al. reported in the June issue of the journal Molecular Biotherapy. WHO is planning a meeting in Geneva, Switzerland in early September to review the African studies on the use of oral alpha interferon for HIV and other viral diseases. At one session, WHO representatives reportedly will meet with Amarillo Cell Culture President Joseph Cummins to discuss conducting placebo controlled trials with Kemron in Uganda. Texas-based Amarillo Cell Culture licenses Kemron from the Japanese company Hayashibara, which owns one-third of Amarillo. In turn, Amarillo has issued a co-exclusive license for Kemron to Interferon Sciences for development and marketing in the U.S. Interferon Sciences currently markets an injectable alpha interferon (Alferon-N) for the treatment of genital warts. According to the AIDS activist group ACT UP, a sizeable number of AIDS and ARC patients in the U.S. are obtaining alpha interferon through the underground market. Hoffmann-La Roche and Schering Plough market injectable forms of the drug (Roferon-A and Intron A, respectively). Roche recently signed a collaborative agreement with U.K.-based Cortecs Ltd. for the development and testing of an oral formulation of Roferon-A.
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